API Manufacturing Validation Expert

2 weeks ago


Duluth, Georgia, United States Validation & Engineering Group Full time
Position Overview

Validation & Engineering Group, Inc. (V&EG) is a premier provider of specialized services across the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices sectors. Our expertise encompasses a range of areas including Laboratory Services, Compliance, Engineering, Project Management, and Validation.

We are in search of a highly skilled and dedicated professional who adheres to the highest ethical standards for the role of:

Validation Specialist for API Manufacturing

Key Responsibilities:

  • Conduct validation activities for API manufacturing processes.
  • Develop and execute validation protocols including IQ, OQ, and PQ.
  • Prepare and manage Design Documentation such as User Requirement Specifications (URS) and Design Specifications (DS).
  • Ensure compliance with cGxP regulations and industry standards.
  • Utilize strong technical writing skills to document validation findings and generate reports.
  • Perform risk assessments and ensure data integrity throughout the validation process.
  • Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).

Qualifications:

  • Bachelor's Degree in a relevant Science or Engineering discipline.
  • A minimum of 3 years of experience in the pharmaceutical, medical device, or biotechnology fields.
  • Proficiency in API process development and scale-up methodologies.
  • Strong understanding of Quality by Design (QbD) principles.
  • Experience with automated control systems and software validation.
  • Proficient in MS Windows and Microsoft Office applications.
  • Excellent communication skills, both written and verbal, with a keen attention to detail.
  • Willingness to work extended hours, including weekends and holidays if necessary.


  • Duluth, Georgia, United States Validation & Engineering Group Full time

    Position OverviewValidation & Engineering Group, Inc. (V&EG) stands at the forefront of providing essential services across various sectors including Pharmaceuticals, Biotechnology, Chemicals, Food, and Medical Devices. Our expertise spans Laboratory Services, Compliance, Engineering, Project Management, and Validation among others.We are currently in search...


  • Duluth, Georgia, United States Validation & Engineering Group Full time

    Position OverviewValidation & Engineering Group, Inc. (V&EG) stands at the forefront of providing essential services across various sectors, including Pharmaceuticals, Biotechnology, Chemicals, Food, and Medical Devices. Our expertise spans Laboratory Services, Compliance, Engineering, Project Management, Validation, and more.We are in search of a skilled...


  • Duluth, Georgia, United States Trane Technologies Full time

    About the RoleWe are seeking a highly skilled Field Service Representative to join our team at Trane Technologies. As a key member of our climate solutions team, you will provide technical support to our dealers and provide comprehensive technical training programs focused on improving service capability and customer satisfaction.Key ResponsibilitiesProvide...


  • Duluth, Georgia, United States Weg Full time

    Job OverviewPosition Summary:WEG Electric Corp. is seeking a Senior Service Engineering Leader to enhance our team. This position involves addressing technical inquiries and providing solutions related to post-sales support, programming, and wiring for all WEG automation products.Key Responsibilities:Lead and support the Field Service team, Warranty...


  • Duluth, Georgia, United States Classic Collision Full time

    About the RoleClassic Collision is seeking a skilled Collision Estimator to join our team. As a Collision Estimator, you will play a critical role in ensuring that our customers receive accurate and timely estimates for their vehicle repairs.Key ResponsibilitiesPrepare detailed estimates for customers and insurance partners, adhering to manufacturer and...


  • Duluth, Georgia, United States American Air Filter International Full time

    Job OverviewAmerican Air Filter International is a leader in providing comprehensive clean air solutions worldwide. With a legacy dating back to 1921, we operate manufacturing facilities in 22 countries and employ over 6000 individuals globally. Our products set the standard for quality and performance across various applications, including commercial,...

  • Service Advisor

    4 days ago


    Duluth, Georgia, United States Hennessy Auto Group Full time

    Job SummaryWe are seeking a skilled Service Advisor to join our team at Hennessy Auto Group. As a Service Advisor, you will play a crucial role in building trust and gaining repeat business with our service customers. You will be the liaison between the customer and technician, ensuring an excellent experience for our clients.Key ResponsibilitiesGreet...


  • Duluth, Georgia, United States American Air Filter International Full time

    Job OverviewAmerican Air Filter International is a leading provider of clean air solutions worldwide, operating since 1921. With a presence in 22 countries and a workforce exceeding 6000 employees, we set the standard for quality and performance in our industry. Our product range serves various sectors, including commercial, industrial, and residential...


  • Duluth, Georgia, United States ONEPOWER Consulting Full time

    Job OverviewPosition: Japanese Bilingual Controls EngineerLocation: Duluth, GASalary: $80K-$100K DOERole SummaryThe Bilingual Controls Engineer will leverage their expertise in control systems, automation, and instrumentation to enhance industrial operations, improve efficiency, ensure safety, and foster technological advancements across various sectors....


  • Duluth, Georgia, United States Nexus Business Solutions LLC Full time

    Job OverviewPosition Summary: The Commercial Operations Manager is tasked with overseeing the Commercial Sales Division. This role encompasses business development, operational management, sales performance evaluation, staff supervision, and ensuring customer satisfaction within the Commercial Sales sector.Supervisory Duties: This position includes direct...


  • Duluth, United States Validation & Engineering Group Full time

    Job DescriptionJob DescriptionValidation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a...

  • Quality Manager

    4 weeks ago


    Duluth, United States Expert Technical Solutions Full time

    Job DescriptionJob DescriptionQuality Manager – Manufacturing OperationsExpert Technical Solutions is seeking a Quality Manager for one of our industry leading clients based out of Atlanta, GA (Duluth). Reporting directly to the VP of Operations, the Quality Manager is responsible for supporting the Operations department by ensuring that all company...


  • Duluth, Minnesota, United States Expert Technical Solutions Full time

    Job OverviewQuality Manager – Manufacturing OperationsExpert Technical Solutions is in search of a Quality Manager to oversee quality assurance processes within a prominent manufacturing environment. This pivotal role reports directly to the VP of Operations and is essential in ensuring that all products and services adhere to established quality...


  • Duluth, Minnesota, United States Expert Technical Solutions Full time

    Job OverviewQuality Manager – Manufacturing OperationsExpert Technical Solutions is in search of a Quality Manager to oversee quality assurance processes within a leading manufacturing organization. This role will report directly to the VP of Operations and is pivotal in ensuring that all products and services adhere to established quality benchmarks.The...


  • Duluth, Minnesota, United States Expert Technical Solutions Full time

    Job OverviewQuality Manager – Manufacturing OperationsExpert Technical Solutions is in search of a Quality Manager to oversee quality assurance for our esteemed clients. This role is pivotal in ensuring that all products and services consistently meet high-quality standards. The Quality Manager will report directly to the VP of Operations and will play a...


  • Duluth, United States Expert Technical Solutions Full time

    Job DescriptionJob DescriptionEngineering Operations Lead – EE / ME - HardwareExpert Technical Solutions is seeking an Engineering Team Lead for one of our industry leading clients based out of Atlanta, GA (Duluth). This person will be a dynamic force at the intersection of leadership and technical excellence. This role requires a distinctive combination...


  • Duluth, Minnesota, United States Cirrus Aircraft Full time

    Job Summary:This role is responsible for developing, implementing, and improving manufacturing processes to meet product specifications and quality standards. The ideal candidate will troubleshoot production issues, coordinate manufacturing launches, and support production to drive key performance indicators.Main Responsibilities:Develop efficient...


  • Duluth, Minnesota, United States Cirrus Aircraft Full time

    Company OverviewCirrus Aircraft is dedicated to providing an aviation experience characterized by innovation, quality, and safety. As a leader in personal aviation, we manufacture the renowned SR Series piston aircraft and the Vision Jet™, the first single-engine personal jet. Job SummaryThe Metal Surface Finishing Expert plays a crucial role in preparing...


  • Duluth, Minnesota, United States Cirrus Aircraft Full time

    Position Overview:The Senior Manufacturing Engineer is accountable for the development, execution, and enhancement of manufacturing processes, methodologies, and controls to align with product specifications and quality benchmarks. This role involves diagnosing production challenges to identify root causes and implement corrective measures. The engineer will...


  • Duluth, Minnesota, United States Georgia Economic Developers Association Inc Full time

    Position Title: Manufacturing and Supply Chain Project CoordinatorCategory: Economic DevelopmentEmployment Type: Full-TimeEducational Background: Bachelor's DegreeThe Georgia Economic Developers Association Inc is dedicated to fostering economic growth and enhancing the quality of life in our communities.Role Overview:As a Manufacturing and Supply Chain...


  • Duluth, Minnesota, United States Cirrus Aircraft Full time

    Position Overview:The Lead Manufacturing Engineer is accountable for the design, execution, and enhancement of manufacturing methodologies, ensuring alignment with product specifications and quality benchmarks. This role involves diagnosing production challenges to identify root causes and implement corrective measures. The engineer will also oversee the...


  • Duluth, United States Cirrus Aircraft Full time

    Job Summary: Responsible for developing, implementing, maintaining, and improving manufacturing processes, methods, and controls in accordance with product specifications and quality standards. Troubleshoots production issues to determine root cause and corrective actions. Coordinates manufacturing launch for new or revised products. Supports production...


  • Duluth, United States Cirrus Design Corporation Full time

    Job DescriptionJob DescriptionJob Summary:Responsible for developing, implementing, maintaining, and improving manufacturing processes, methods, and controls in accordance with product specifications and quality standards. Troubleshoots production issues to determine root cause and corrective actions. Coordinates manufacturing launch for new or revised...


  • Duluth, United States Cirrus Aircraft Full time

    Job Summary: Responsible for developing, implementing, maintaining, and improving manufacturing processes, methods, and controls in accordance with product specifications and quality standards. Troubleshoots production issues to determine root cause and corrective actions. Coordinates manufacturing launch for new or revised products. Supports production to...


  • Duluth, United States Renesas Electronics Full time

    Job DescriptionJob DescriptionCompany DescriptionRenesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering product solutions in the automotive, industrial, infrastructure and IoT markets. Our robust product...


  • Duluth, United States Renesas Electronics Full time

    Job DescriptionJob DescriptionCompany DescriptionRenesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering product solutions in the automotive, industrial, infrastructure and IoT markets. Our robust product...


  • Duluth, Minnesota, United States WestRock Company Full time

    Job Title: Payroll Operations AnalystAt WestRock Company, we are a global leader in sustainable paper and packaging solutions. Our team of materials scientists, packaging designers, mechanical engineers, and manufacturing experts share a common purpose: to innovate boldly and package sustainably.The OpportunityWe are seeking a highly skilled Payroll...

  • Body Waxing Expert

    2 weeks ago


    Duluth, Minnesota, United States Waxing The City of St. Cloud Full time

    Position OverviewPerks of Joining Us:401(k) PlanPerformance-Based BonusesAttractive Salary PackageDental CoverageEmployee DiscountsFlexible Work HoursHealth InsurancePaid LeaveJoin the Team at Waxing the City of St. Cloud*NEW MANAGEMENT IN PLACE*At Waxing the City, we appreciate our talented service professionals who excel in the art of waxing. Our...

  • Regional Sales Executive

    5 minutes ago


    Duluth, Minnesota, United States Metal Sales Manufacturing Corporation Full time

    Position OverviewCompany OverviewMetal Sales Manufacturing Corporation stands as a leading entity in the production of metal roofing and wall panel solutions for both residential and commercial construction sectors. We are in search of a skilled Regional Sales Executive with a background in the Building Products sector to enhance our operations.Role...


  • Duluth, Minnesota, United States NALS Apartment Homes Full time

    NALS Apartment Homes values the importance of creating a welcoming environment for both residents and employees. We believe that every apartment should feel like home, and we are committed to fostering a culture of growth and collaboration among our team members.We are currently seeking a dedicated Maintenance Technician to join our team.What We...